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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Transcutaneous, For Arthritis
510(k) Number K142236
Device Name BioniCare Hand System
Applicant
VISION QUEST INDUSTRIES, INC.
1390 DECISION STREET, SUITE A
VISTA,  CA  92081
Applicant Contact MOHAMED OUERGHI
Correspondent
VISION QUEST INDUSTRIES, INC.
1390 DECISION STREET, SUITE A
VISTA,  CA  92081
Correspondent Contact MOHAMED OUERGHI
Regulation Number882.5890
Classification Product Code
NYN  
Date Received08/13/2014
Decision Date 03/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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